Phase 3, Novavax vaccine clinical trials in Omaha
OMAHA, Neb. (WOWT) – Another potential COVID vaccine is nearing the finish line. Novavax, launched in late 2020, was the fifth drug to be re-viewed as a potential weapon for the coronavirus pandemic.
Phase 3 vaccine studies have now been reached and are being tested at Meridian Clinical Research, an Omaha-based company.
Unlike its predecessors Pfizer and Moderna, Novavax is, according to Dr. Brandon Essink is more of an influenza vaccine on a molecular level.
Dr. Bryan Health’s Essink specializes in family medicine and telemedicine as well as being the medical director for Meridian. He’s been their lead investigator since 2003 and wants the public to understand what makes Novavax so special.
“It doesn’t make your body make the spike protein. This will do more to help your body recognize the spike protein and make antibodies. “Said Essink.
He went on to explain that Novavax has genetic changes and uses a lab-made version of the SARS-CoV-2 spike protein that won’t make you sick. It contains an additional ingredient called an adjuvant that will put your immune system into action when it comes across the disease.
Action is exactly what Jason S., a process volunteer, is looking for. The Nebraska resident began his journey earlier this year attending the trial and is expected to be shot for the second time in a few days.
“It gives me a little sense of control,” he said.
Jason shared that part of the reason he signed up was because he was already wearing his mask and being socially distant, but wanted to go a step further to do whatever was necessary to take the pandemic into the background move.
Describing his previous experience as “smooth,” he said he felt his efforts were paying off.
“I had very, very slight side effects. Just a little tenderness, ”he said. “However, I don’t know if I got the placebo or the actual shot. That may change when I get my second dose.”
According to Dr. Essink not only normal, but also a good sign that the body knows the vaccine is working.
“You could get a fever. Your joints may be sore, your muscles may be sore. Headaches tend to be very common just because you are strengthening your immune system and that is the goal, ”said Essink.
Meridian has analysts, doctors, clinicians, and more working as middlemen around the clock. This includes everyone from those who actually give the vaccine, to the independent reviewers who keep it running smoothly, to the people who enter the data and share it with stakeholders.
Phase 3 studies aim to determine that Novavax is successful in preventing COVID-19 rather than treating it. And while progress is being shown, Dr. Essink also said it would be months before the FDA clears it for emergency clearance. That’s because Novavax needs around 10,000 more patients to volunteer.
“Research is not for everyone, but it is something that people should look at and consider to help humanity,” said Essink. “And that’s an easy way. It’s all volunteer-based and it may be the fastest way people are currently getting a vaccine as there is a hierarchy in terms of diffusion. “
For those with questions about the process, Jason said he would recommend it.
“They explained very well what could and what could happen and I felt very well informed all along.” he said.
Even if Novavax becomes the next available COVID-19 vaccine, Dr. Never give Essink enough.
“As many different bullets as we can find for the gun are better to help us … in case things mutate,” he said. “And we know the coronavirus will mutate.”
If you have any questions or would like to participate in Novavax’s clinical trials, please visit the Meridian Clinical Research website for more information.
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